FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
3289–3312 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 25, 2016
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6,...
K153617 · OBJ
Boston Scientific Corporation
Cardiovascular · 69d
Cleared Feb 25, 2016
Occlusion Perfusion Catheter
K153488 · QEY
Advanced Catheter Therapies, Inc.
Cardiovascular · 83d
Cleared Feb 25, 2016
ASAHI Astato XS 40
K153443 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 90d
Cleared Feb 25, 2016
VITAL SIGNS MONITOR
K153135 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 118d
Cleared Feb 24, 2016
HeartLight Deflectable Sheath
K152310 · DRA
Cardiofocus, Inc.
Cardiovascular · 194d
Cleared Feb 23, 2016
Spot Skan
K152831 · DXN
Skanray Technologies Private Limited
Cardiovascular · 147d
Cleared Feb 23, 2016
Navik 3D
K152160 · DQK
Apn Health, LLC
Cardiovascular · 204d
Cleared Feb 23, 2016
ANI Monitor
K142969 · DPS
Mdoloris Medical Systems Sas
Cardiovascular · 497d
Cleared Feb 19, 2016
Oscar 2
K151520 · DXN
Suntech Medical, Inc.
Cardiovascular · 259d
Cleared Feb 18, 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 140d
Cleared Feb 18, 2016
Recovery Cone Removal System
K152136 · MMX
C.R. Bard, Inc.
Cardiovascular · 202d
Cleared Feb 18, 2016
Arm automatic blood pressure monitor
K151258 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 282d
Cleared Feb 16, 2016
FUSION Vascular Graft
K153523 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 69d
Cleared Feb 16, 2016
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -...
K152485 · LOX
Ostial Corporation
Cardiovascular · 169d
Cleared Feb 14, 2016
Star 60
K151512 · MWI
Skanray Technologies Private Limited
Cardiovascular · 255d
Cleared Feb 12, 2016
Digital Electrocardiograph
K160092 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 28d
Cleared Feb 12, 2016
PTFE Super Sheath Introducer 2.1
K153246 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 95d
Cleared Feb 12, 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 112d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · DQX
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Feb 12, 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · MWI
Masimo Corporation
Cardiovascular · 239d
Cleared Feb 11, 2016
OptoWire Deux
K152991 · DQX
Opsens
Cardiovascular · 121d
Cleared Feb 09, 2016
Dictum Health
K152645 · MWI
Dictum Health, Inc.
Cardiovascular · 146d
Cleared Feb 05, 2016
Bridge Occlusion Balloon
K153530 · MJN
Spectranetics, Inc.
Cardiovascular · 58d
Cleared Feb 05, 2016
PC ECG
K152427 · DPS
Edan Instruments, Inc.
Cardiovascular · 163d